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Sticares InterACT
has broad
experience
with
Regulatory
Affairs
throughout
Europe.
We are fully
compliant
with
ICH requirements
and guidelines
and cooperate
with
all major regional
and national
regulatory
agencies
in Europe.
We have great
knowledge
of the regulatory
requirements
in all countries
where
we are based
and can
therefore
guarantee
a correct and timely
submission
in order not
to delay
the start of the study.
For this,
we have developed
guidelines
specific
for
the requirements
in all European
countries.
Next to
submission
for
new
studies, we are also
experienced
in the submission
of amendments
and safety
reporting
to Regulatory
Authorities
and Ethics
Committees.
We are familiar with
the EU directives
2001/20/EC and 2005/28/EC. We can
work
with
the EudraCT
database and have experience
with
the EMA. Our
flexibility
assures
that
we can
handle
all projects,
no
matter the size,
and can
take
on
complete programs, but
are also
happy to work
on
individual
tasks.
Because of
our
experience
in the field of cardiovascular,
metabolic
disorders and oncology, we can
help you
with
the special needs
required
for
these studies.
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